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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03589404
Other study ID # 2011-KAEK-25 2018/04-24
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 15, 2018
Est. completion date November 15, 2019

Study information

Verified date December 2019
Source Bursa Yüksek Ihtisas Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal wall.


Description:

The investigators aimed to investigate the effects of pneumoperitoneum administered during laparoscopic cholecystectomy on abdominal wall oxygenation and postoperative pain scores.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date November 15, 2019
Est. primary completion date November 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients who were in the American Society of Anesthesiologists (ASA) I-III class

- Underwent laparoscopic cholecystectomy

Exclusion Criteria:

- Previous surgeon surgeon

- Local anesthetic allergy,

- Bleeding is a diathesis disorder

- Mental impairment,

- Allergic to the drugs used,

- Patients who are not reluctant to participate in the study,

- Presence of infection in the block area,

- Patients whose body mass index is over 30

Study Design


Related Conditions & MeSH terms


Intervention

Device:
rso2
The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.

Locations

Country Name City State
Turkey Bursa Yuksek Ihtisas Training and Research Hospital Bursa

Sponsors (1)

Lead Sponsor Collaborator
Bursa Yüksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary rso2 The regional oxymetry probe (Medtronic Quick Assist INVOS™ (In-Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter) will be placed in the abdominal region of the umbilicus in the middle clavicular line perioperative
Secondary Visual Analog Scale Visual Analog Scale was used for pain.Pain intensity was measured using 0-10 cm visual analogue scale (VAS). (0=no pain, 10=intolerable pain) Postoperative 24 hours
Secondary analgesic use analgesic use Postoperative 24 hours
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